Friday, December 16, 2016

The last two posts on this blog detail how - for all practical purposes - UCB (the large Belgian pharmaceutical company) has lost the patent to one of its main drugs (Vimpat) and not told the market. See here and here.

EBIT is likely to fall 30-40 percent eventually. The company might dain one day to fill shareholders in on the details. The numbers are really not pretty but without proper company disclosure it is impossible to make an accurate estimate.

For almost two weeks I have expected the UCB to make a statement. But they have kept silent failing to disclose key information to the market.

The patent's death certificate was only sent by the United States Patent and Trademark office last Monday and there are different time-zones and languages to deal with. So I drafted the blog-posts gently, expecting a confirming press release along with accurate statement of prognosis from the company.

The patents death certificate is however almost certainly final. This is a clear statement of fact by the Patent Office against the patent. Appeals against patents are almost always on matters of law - and courts are reluctant to overturn fact-finders. All previous actions against this patent have been on law. A finding of fact against UCB is devastating.

This is not ordinary course of business patent litigation. In the ordinary course of business UCB has wound up in patent disputes with other companies (eg Mylan, Argentum). And those disputes have been where the assumption is that UCB has a valid patent.

This time it is in dispute with the US Government. And the US Government is stating there is no valid patent.

Ask other European companies how disputes with the US Government pan out.

Moreover the burden of proof has changed. UCB now has to get its patent approved under de-novo standards when the Patent Office has already rejected the patent.

Of course none of this seems to warrant any statement from UCB.

Lower standards

I am going to be blunt. Withholding a piece of information this significant from the market in the US would result in a fairly nasty SEC inquiry complete with subpoenas to determine who knew what and when. I have made relatively few investments in Belgium so I can't tell whether the Belgian regulatory standards are lower or the standards are just lower at UCB.

But standards are very low here.

In the US if a single insider has sold whilst in possession of this information (which was unreleased to the market) they could expect close investigation by Preet Bharara. I don't know what standards apply in Belgium.

As stated in previous postsI found the IR officers we met of very high integrity. But this has to extend higher than this. I think it has to rise to the level of Jean-Christophe Tellier - the well regarded CEO.

Monday, December 12, 2016

This is a follow up to last Friday's post about UCB - the large Belgian pharmaceuticals company. It probably helps if you read that post first.

In Friday's post I outlined the state of play regarding UCB's important Vimpat patent. Disputes about that patent have been background for the stock for some time. When I went to visit UCB in Belgium (1 December 2015) the IR officers were straightforward about this. Third party patent challenges were the bear story on the stock.

But UCB has since then touted victories in their patent disputes and regularly touted extensions of the Vimpat franchise.

UCB has made many press releases detailing just how important the Vimpat franchise is to them.

When the CEO (Jean-Christophe Tellier) was appointed the press release stated: "Jean-Christophe Tellier joined the company in 2011 and was instrumental in establishing the company’s current strategy; he has played a key role in driving the growth of UCB’s three core medicines, Cimzia®, Vimpat® and Neupro®."

UCB has been active in touting Vimpat both in the EU and the US as a monotherapy for epilepsy. (See here and here.)

UCB has been extremely active extending labels for Vimpat in Japan. (See here for an example.)

Indeed extensions of the Vimpat franchise have been important in UCB's growth strategy.

So it was deeply surprising to us when UCB neglected to tell the market that US Patent Office had reviewed the patent (an ex-parte review) and had decided to withdraw the patent entirely. [You can find the letter that the Patent Office sent here.]This is an unusual move. Since the ex parte examination system was introduced (35 years ago) about 13,500 ex parte requests for examination has been made just over a thousand of them have had all claims rejected. You can find statistics here. Rejected here is a term of art. A claim is "objected" for all sorts of formal reasons like the claims not being properly grouped. A "rejection" is a determination that the claim is not patentable - and is appellable to the Patent Trial and Appeal Board (a court) and then to the court system. This is altogether a different type of threat to UCB. Past patent disputes have been with other companies wanting to release a generic - and thus far UCB has either had the case thrown out or got a significant delay. These are standard commercial disputes with commercial parties. And in every one of these disputes the court has worked on the assumption that UCB has a valid patent and the question is whether the other party is infringing on this patent.

This dispute is with the US Government. The US Government has reviewed past decisions and decided that Vimpat is simply non-patentable. That is the US Government has determined that UCB does not own a valid patent. Sure UCB has two months to try and convince a (well informed) patent examiner otherwise - but their chances of this are low. The patent examiner will be experienced in this area and it is not as if the bureaucrat was uninformed that this was a controversial and important case.

After the two months has elapsed UCB could appeal to the Patent Trial and Appeal Board. However the standard here is the de-novo patent standard. The situation is as if Vimpat had its original patent comprehensively rejected and it has to appeal to a court against the scientist/reviewers at the Patent Office. The courts are usually pretty deferential to the examiners at the Patent Office on the basis that they have the disinterested expertise to assess patents. In this case Johnny Railey was the examiner and he is amongst the most experienced biotech patent examiners in the US. You can find his linked in CV here. You can find a very extensive list of patents in which he was the examiner here. Appeals of this kind almost always fail. As Johnny Railey is amongst the most experienced patent examiners the chance of an appeal succeeding is even lower.For practical purposes the Vimpat patent is almost certainly dead - and UCB's much ballyhooed growth strategy will die with it.I am surprised at the lack of a management press release.

Disputes with the US Government

UCB has press released interim victories in District Court against commercial claimants on the Vimpat patent.

Their IR officers have been willing to give up-to-date reports of the (mostly) favourable commercial disputes they have.

But there is not a word here that their (new) dispute is with the US Government and the default position from here (statistically likely to be upheld) is that they will lose their patent in its entirety.

Not disclosing a business-critical dispute with the US Government is strange.

Whatever: shareholders should ask themselves how other European companies have prevailed in dispute with the US Government.

Friday, December 9, 2016

UCB is a Belgium-based biopharmaceutical and specialty chemical company that specialises in two therapeutic areas: diseases of the central nervous system and immunology. The main central nervous system speciality is epilepsy and the main drug in this area is Vimpat. (UCB revenue mostly comes from four drugs of which Vimpat is one.)

We went to visit UCB once, a cold and wet wintery day where we got modestly lost in Belgium.

The investor relations people were straightforward. We were new to the story and our notes state clearly that generic challenges to the Vimpat patent were the main bear story for the stock. Our notes also talk about Keppra - another epilepsy drug. When it went off patent revenues dropped substantially. Keppra was an famous "patent cliff" drug.

UCB isn’t totally out of the woods, though. In late May, New York-based generics maker Argentum Pharmaceuticals won an inter partes review of Vimpat’s patent protection by the U.S. Patent & Trademark Office (PTO)’s Patent Trial & Appeal Board (PTAB). And that decision may not be handed down until next May.

Still, court’s decision is a “long-awaited sentiment boost” for UCB, whose shares had fallen by about 17% so far this year, Citigroup analysts wrote in a Monday note seen by Bloomberg. Despite the lingering risk of patent invalidation, they wrote, “we expect market confidence to improve.”

As noted Argentum Pharmaceuticals won an inter-parties review of Vimpat's patent. Argentum's press release however noted an even more aggressive request. To quote:

Argentum also filed an ex parte reexamination request against this same patent that raises additional grounds of unpatentability than those in the IPR. A decision by the PTO on Argentum's reexamination request is due no later than July 29, 2016.

This is mentioned as afterthought in the press release because it is a really aggressive claim. Argentum asked the Patent Office itself to review the patent it previously granted and presumably throw out the original patent.

Given the afterthought nature of that request I suspect even Argentum will be surprised that the ex-parte review rejected all thirteen claims of the Vimpat patent.

In other words the Patent Office has thrown out the patent.

This is all in a letter dated 5 December 2016 (that is just a few days ago). You can find that letter here. And according to that letter UCB has only two months to dispute the total rejection of the patent by the patent office.

This rejection will of course be followed by Argentum and Mylan (and probably other companies) commencing distribution of a generic for Vimpat. Mylan were behind the above-mentioned court challenge.

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It is - given the significance of this to the business - perhaps a little unusual that UCB has made no press release.

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Is this the beginning of a new, more aggressive patent office?

The political pressure in the US to do something to reduce drug prices is large. In the past election this was one area of near universal agreement.

I am wondering whether we are going to see this sort of action by the Patent Office more widely.

If the trend is more widespread it could be bad news for pharma investors generally.

Thursday, December 8, 2016

There is an obsession in the liberal press about Donald Trump's opaque personal finances and the repeated appearance that he has a conflict of interest.

I am obsessed too. But I want him to have more conflicts.

I want a Trump Tower paying royalties to the Donald in every country that matters, indeed in most cities. I want them in countries that do not matter. Frankly I would love them all over China, India and Pakistan.

If the Donald leaves office safely with 100 billion dollar net worth it would be just fine with me.

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You see if the Donald has economic interests in some country he will not wind up on any ill-advised military adventures there. Indeed he would tend to prefer open economic relations, as much as anything so he can get his cash out.

Trump corruption is wonderful then because it preserves the open and (relatively) peaceful world I like.

So please Donald - more conflicts of interest - big international conflicts of interest. I want them yuuuge.

In plain english Flotek makes a chemical mix which makes sand-water mixes slippery so you can get more sand into fractures when you fracture an oil and gas reservoir. Their chemical mix is a surfactant.

There are many suppliers of surfactants. The product is a commodity.

However Flotek sell their product as somehow special. The claim: their surfactant is a "complex nano-fluid", but it is really a mix of d-limonene (the oil from orange peel) and isopropyl alcohol.

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This blog once showed that data Flotek provided for pitching their complex nano-fluid was either (a) made up or (b) did not support the idea that their fluid was particularly effective.

At the time Flotek claimed they had a software sales tool (that ran on an iPad) called FracMax which was critical to demonstrating their fluid effective - but we could not find a working copy of FracMax and could not find anyone who had ever seen one.

This was problematic. Flotek told the market that FracMax was their main selling tool.

Whatever FracMax has disappeared from Flotek's literature.

So their main selling tool was also BS.

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All this should have been the death-knell for the stock. But it wasn't. Sure the stock is lower but not much (given the decline in oil and gas volumes) and somehow people still believe the "complex nano-fluid" story. I have never met a serious Flotek owner - so the stock price remains a mystery to me.

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Today FourWorld Capital Management (an outfit I had never heard of) put out an updated and more thorough analysis of Flotek.

General disclaimer

The content contained in this blog represents the opinions of Mr. Hempton. Mr. Hempton may hold either long or short positions in securities of various companies discussed in the blog based upon Mr. Hempton's recommendations. The commentary in this blog in no way constitutes a solicitation of business or investment advice. In fact, it should not be relied upon in making investment decisions, ever. It is intended solely for the entertainment of the reader, and the author. In particular this blog is not directed for investment purposes at US Persons.